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Custom plastic implants for skull and face defects under scrutiny in new study

NCT ID NCT05362370

Disease control Sponsor: Stryker Craniomaxillofacial Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study is checking how safe and effective Stryker's custom-made PEEK implants are for fixing bone and soft tissue problems in the skull and face. About 99 people who need these implants will be followed for up to 24 months after surgery. The main goal is to see how often infections or other serious problems happen.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
PEEK Customized Implant (a plastic-like medical device used to reconstruct bone defects in the skull and face)
What this could lead to
If successful, this could confirm that PEEK implants are a safe and effective option for repairing skull and facial bone defects, improving appearance and function.
What could go wrong
This is a post-market study, so the device is already approved. Risks include infection, implant failure, or serious side effects. The study is relatively small (99 people) and not randomized.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 99 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2023

Expected to finish

Jun 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Patients with cranial and craniofacial defects requiring augmentation and/or restoration, e.g. following tumor resection, trauma, vascular conditions, or stroke requiring craniectomy, due to previously failed cranioplasty, or bone flap resorption.

Ages

42 months and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria 1. Subject is eligible for a PEEK customized implant as per routine clinical practice. 2. Subject is 12 years of age or older (Europe only). 3. Subject is 3.5 years of age or older (USA only). 4. Adult subjects able to give consent. 5. Subjects under the age of 18 will have a legal representative or parents (France - both parents must sign) to provide informed consent. 6. Subjects who are unable to give consent themselves but have a legally authorized representative that may consent on their behalf. Exclusion Criteria 1. Subject has an active systemic or local infection. 2. Subject has known allergy to plastic or polymers and/or known sensitivity to foreign bodies. 3. Comprised bone due to poor blood supply, disease, infection or prior implantation, which would not allow adequate support or fixation of the implant. 4. Mental or neuromuscular disorder which could create an unacceptable risk of implant instability or implant fixation failure, or complications in postoperative care. 5. Knowingly pregnant or nursing women. 6. Concomitant participation in other clinical trials related to cranioplasty. 7. Subject who has an expected survival rate of less than 2 years, in the opinion of the investigator who takes consent.

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Conditions

The condition(s) this trial relates to.

Craniofacial Abnormalities head injury

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Craniofacial abnormalities Craniofacial injuries Cranioplasty

Contacts and locations

Locations

  • APHP - Hôpital Lariboisière Neurochirurgie 2 rue Ambroise Paré

    Paris, Paris France, 75010, France

  • CHU Nantes - Hopital Guillaume et Rene Laënnec, Cedex 1

    Nantes, Pays de la Loire Region, 44093, France

  • Department of Neurological Surgery

    New Brunswick, New Jersey, 07101-1709, United States

  • Department of Neurological Surgery, 710 West 168th Street, 4th Floor, New York Presbyterian Hospital

    New York, New York, 10032, United States

  • Klinik für Neurochirurgie Klinikum Dortmund Münsterstr. 240

    Dortmund, North Rhine-Westphalia, 44145, Germany

  • Lewis Katz School of Medicine at Temple University, 3401 North Broad Street

    Philadelphia, Pennsylvania, 19140, United States

  • Medical University of South Carolina, Oral & Maxillofacial Surgery, 173 Ashley Avenue, Charleston, USA

    Charleston, South Carolina, 29425, United States

  • Neurosurgery, Emergency and Major Trauma (NET) Research | Division of Medicine | Imperial College Healthcare NHS Trust

    London, London, SW7 2AZ, United Kingdom

  • Pierre-Paul Riquet Hospital, Place du Docteur Baylac, Cedex 9

    Toulouse, Occitanie, TSA 40031 - 31059, France

  • Servicio de Neurocirugía Hospital Universitario La Paz.

    Madrid, Madrid, 28046, Spain

  • St. Barbara-Klinik Hamm GmbH Hamm Heessen und St. Josef-Krankenhaus Hamm-Bockum-Hövel Am Heessener Wald 1 | 1263

    Hamm, Hamm, 59073, Germany

  • University of Louisville 501 E. Broadway, Suite 210

    Louisville, Kentucky, 40202, United States

  • Universitätsklinik für Neurochirurgie Auenbruggerplatz 29

    Graz, 8036, Austria

More trials for these conditions

Other studies related to the condition(s) this trial covers.